Motion style acupuncture treatment (MSAT) for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol

Joon-Shik Shin, In-Hyuk Ha, Tae-Gyu Lee, Youngkwon Choi, Byoung-Yoon Park, Me-riong Kim, Myeong Soo Lee, Joon-Shik Shin, In-Hyuk Ha, Tae-Gyu Lee, Youngkwon Choi, Byoung-Yoon Park, Me-riong Kim, Myeong Soo Lee

Abstract

Background: Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability.

Methods/design: This study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI) value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID) injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS) of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR). Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.

Discussion: The results of this trial will be discussed.

Trial registration: ClinicalTrial.gov NCT01315561.

Figures

Figure 1
Figure 1
The Flow of Participants.

References

    1. Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007;25(2):353–371. doi: 10.1016/j.ncl.2007.01.004.
    1. Luo X, Pietrobon R, Sun SX, Liu GG, Hey L. Estimates and patterns of direct health care expenditures among individuals with back pain in the United States. Spine (Phila Pa 1976) 2004;29(1):79–86. doi: 10.1097/01.BRS.0000105527.13866.0F.
    1. Pengel LH, Herbert RD, Maher CG, Refshauge KM. Acute low back pain: systematic review of its prognosis. BMJ. 2003;327(7410):323. doi: 10.1136/bmj.327.7410.323.
    1. Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976) 1987;12(7):632–644. doi: 10.1097/00007632-198709000-00002.
    1. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646–656.
    1. Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006;332(7555):1430–1434. doi: 10.1136/bmj.332.7555.1430.
    1. Evans GR, University of Bristol. Low back pain: an evaluation of therapeutic interventions. University of Bristol, Health Care Evaluation Unit; 1996. Health Care Evaluation Unit.
    1. Bigos SJ. Acute low back problems in adults. Rockville, Md. Executive Office Center, Suite 501, 2101 E. Jefferson St., Rockville, 20852: U.S. Dept. of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research; 1994.
    1. Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK. Clinical Efficacy Assessment Subcommittee of the American College of Physicians, American College of Physicians, American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147(7):478–491.
    1. van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A. COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006;15(Suppl 2):S169–91.
    1. Roelofs PDDM, Deyo RA, Koes BW, Scholten RJPM, Van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. Cochrane Database Syst Rev. 2008. p. CD000396. (pub3)
    1. Graß H, Bertram C, Schuff A, Dettmeyer R. PHARMACOLOGY OF ACUTE PAIN Intramuscular injection of diclofenac Forensic aspects of risk assessment and informed Consent. Rechtsmedizin. 2006;16(3):161–164. doi: 10.1007/s00194-006-0385-z.
    1. Naesdal J, Brown K. NSAID-associated adverse effects and acid control aids to prevent them: a review of current treatment options. Drug Saf. 2006;29(2):119–132. doi: 10.2165/00002018-200629020-00002.
    1. Herrmann WA, Geertsen MS. Efficacy and safety of lornoxicam compared with placebo and diclofenac in acute sciatica/lumbo-sciatica: an analysis from a randomised, double-blind, multicentre, parallel-group study. Internat J Clin Prac. 2009;63(11):1613–1621. doi: 10.1111/j.1742-1241.2009.02187.x.
    1. Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976) 2005;30(8):944–963. doi: 10.1097/01.brs.0000158941.21571.01.
    1. Park JJ, Shin J, Choi Y, Youn Y, Lee S, Kwon SR, Lee H, Kang MH, Ha IH, Shin I. Integrative package for low back pain with leg pain in Korea: a prospective cohort study. Complement Ther Med. 2010;18(2):78–86. doi: 10.1016/j.ctim.2010.02.003.
    1. Machin D, Machin D. Sample size tables for clinical studies. 2. Oxford England; Malden, MA, USA: Blackwell Science; 1997.
    1. World Health Organization. Regional Office for the Western Pacific. WHO standard acupuncture point locations in the Western Pacific Region. Manila: World Health Organization, Western Pacific Region; 2008.
    1. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. doi: 10.1016/S0304-3959(01)00349-9.
    1. Turk DC, Rudy TE, Sorkin BA. Neglected topics in chronic pain treatment outcome studies: determination of success. Pain. 1993;53(1):3–16. doi: 10.1016/0304-3959(93)90049-U.
    1. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976) 2000;25(22):2940–52. doi: 10.1097/00007632-200011150-00017. discussion 2952.
    1. Jeon CH, Kim DJ, Kim SK, Kim DJ, Lee HM, Park HJ. Validation in the cross-cultural adaptation of the Korean version of the Oswestry Disability Index. J Korean Med Sci. 2006;21(6):1092–1097. doi: 10.3346/jkms.2006.21.6.1092.
    1. Guy W, National Institute of Mental Health. Psychopharmacology Research Branch, Early Clinical Drug Evaluation Program. ECDEU assessment manual for psychopharmacology. Rockville, Md.: U. S. Dept. of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976. Rev ed.
    1. Saur PM, Ensink FB, Frese K, Seeger D, Hildebrandt J. Lumbar range of motion: reliability and validity of the inclinometer technique in the clinical measurement of trunk flexibility. Spine (Phila Pa 1976) 1996;21(11):1332–1338. doi: 10.1097/00007632-199606010-00011.
    1. Hart DL, Werneke MW, Pengel LHM, Refshauge KM, Maher CG. Responsiveness of pain, disability, and physical impairment outcomes in patients with low back pain. Spine (Phila Pa 1976) 2004;29(8):879–883. doi: 10.1097/00007632-200404150-00011.
    1. Chow R, Adams R, Herbert R. Straight leg raise test high reliability is not a motor memory artefact. Aust J Physiother. 1994;40:107–111.
    1. Rebain R, Baxter GD, McDonough S. A systematic review of the passive straight leg raising test as a diagnostic aid for low back pain (1989 to 2000) Spine (Phila Pa 1976) 2002;27(17):E388–395. doi: 10.1097/00007632-200209010-00025.

Source: PubMed

3
購読する